NCT02835781

Acellular Dermal Matrix in Breast Reconstruction

Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University Hospital Bratislava · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.

Detailed description

This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Acellular dermal matrix implantation	Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation.

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-01-01
• Completion: 2016-06-01
• First posted: 2016-07-18
• Last updated: 2016-07-18

Locations

1 site across 1 country: Slovakia